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Hepatitis C, Chronic clinical trials

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NCT ID: NCT01057667 Completed - Clinical trials for Hepatitis C, Chronic

A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4

Start date: February 2010
Phase: Phase 2
Study type: Interventional

This equally randomized (1:1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients achieving a rapid virological response (RVR) at week 4, sustained through week 22, will stop all treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus for another 24 weeks up to week 48. Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. Anticipated time on study treatment is up to 48 weeks. Target sample size is <200.

NCT ID: NCT01055821 Completed - Clinical trials for Chronic Hepatitis C Infection

Efficacy of the Therapeutic Vaccine TG4040 Combined With Pegylated Interferon and Ribavirin in Chronic HCV Patients

HCVac
Start date: May 2010
Phase: Phase 2
Study type: Interventional

The primary objective of this protocol is to study the effect of the standard of care in hepatitis C (pegylated interferon and ribavirin) associated with therapeutic vaccine TG4040 on the viral load of treatment-naïve patients with chronic genotype 1 hepatitis C infection.

NCT ID: NCT01054742 Completed - Hepatitis C Clinical Trials

Observational Study of Patients With Chronic Hepatitis C Virus (HCV) Infected With HCV Genotype 1 Low Virus Load (LVL 1) and Effect of PegIntron Plus Rebetol Treatment (Study P04793 Part 2)

Start date: December 2009
Phase: N/A
Study type: Observational

The purpose of this observational study was to provide summary data from participants who relapsed at the end of the follow-up phase after 24 weeks of treatment with standard care PegIntron plus ribavirin in Part 1 of the study (NCT00709228) and who then received retreatment during Part 2 of the study. Relapse was defined as having a positive virology result at the Week 24 post-treatment follow-up, after a negative result at the Week 24 end-of-treatment time point. Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels were measured at Day 1 and Weeks 12, 24, and 48 of the extension, and at Follow-up Week 24.

NCT ID: NCT01054573 Completed - Clinical trials for Hepatitis C, Chronic

VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo

Start date: April 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and tolerability of telaprevir in combination with standard treatment will be evaluated.

NCT ID: NCT01033448 Completed - Clinical trials for Hepatitis C, Chronic

A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response

Start date: December 2009
Phase: Phase 4
Study type: Interventional

This open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24 weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders will be enrolled in this study in order to receive additional 24 weeks of treatment. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.

NCT ID: NCT01033045 Completed - Hepatitis C Clinical Trials

Epidemiological Study to Evaluate the Management of Patients With Chronic Hepatitis C and Previous Treatment Failure

Start date: September 2009
Phase: N/A
Study type: Observational

The purpose of this study is to describe the management of patients with chronic hepatitis C and previous treatment failure.

NCT ID: NCT01023035 Completed - Clinical trials for Hepatitis C, Chronic

Boceprevir/Peginterferon/Ribavirin for Chronic Hepatitis C: Erythropoietin Use Versus Ribavirin Dose Reduction for Anemia (P06086 AM2)

Start date: December 7, 2009
Phase: Phase 3
Study type: Interventional

The current trial is designed to prospectively explore the safety of erythropoietin use for the treatment of anemia during boceprevir plus peginterferon alfa-2b/Ribavirin (PEG2b/RBV) therapy and to assess its relationship to efficacy. All participants in this trial will be treated with the triple combination of boceprevir plus PEG2b/RBV. If a participant becomes anemic during treatment, the participant will be randomized to one of two therapeutic strategies for management of anemia (erythropoietin use versus RBV dose reduction).

NCT ID: NCT01018615 Completed - Chronic Hepatitis C Clinical Trials

Safety, Metabolism, and Antioxidant Activity of Silymarin and Green Tea Extract in Patients With Chronic Hepatitis C

Start date: November 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine if the safety, metabolism, and antioxidant activity of silymarin and green tea extract are changed when they are given in combination to patients with chronic hepatitis C infection.

NCT ID: NCT01012895 Completed - Chronic Hepatitis C Clinical Trials

Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care

Start date: December 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the treatment of Hepatitis C in patients who have not responded to prior therapy.

NCT ID: NCT01011166 Completed - Clinical trials for Chronic Hepatitis C Infection

Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin (MK-2355-004)

Start date: November 2009
Phase: Phase 2
Study type: Interventional

This study will assess short term safety, antiviral activity and pharmacokinetics (PK) of IDX184 in combination with Peg-interferon (Peg-IFN)/Ribavirin (RBV) in participants with hepatitis C virus (HCV) genotype (GT) 1 infection. These data will guide dose selection for future, longer term studies.